JP5004480B2 - Specimen collection device and method of using the same - Google Patents

Description

(background)
(1. Field of the Invention)
The present disclosure relates to surgical confinement devices and methods of use thereof. More specifically, the present disclosure relates to specimen collection pouches and their use in minimally invasive surgical procedures.

(2. Technical background)
Laparoscopic and endoscopic surgical procedures are minimally invasive procedures in which surgery is performed in the body by using an elongated instrument inserted through a small entrance opening in the body. Is called. The initial opening in the body tissue for passing an endoscopic or laparoscopic instrument inside the body can be the body's natural passage, or the opening can be a tissue penetrating instrument ( For example, trocar). Laparoscopic and endoscopic procedures generally involve any instrument inserted into the body being sealed (i.e., such that the instrument or an operating area of the body (e.g., the peritoneum) can be insufflated with gas). Conditions must be in place to ensure that no gas enters or exits the body through the incision). The mechanical actuation of such an instrument is, for the most part, the movement of the various elements along the longitudinal axis, together with a structure provided to convert longitudinal movement into lateral movement, if necessary. Disturbed.

  Endoscopic or laparoscopic surgery is a conventional surgical procedure because the tubes, instruments, and any required punctures or incisions for endoscopes or laparoscopes are relatively narrow. Compared to (this procedure requires the surgeon to cut large areas of body tissue). Thus, laparoscopic or endoscopic surgery minimizes trauma to the patient and reduces patient recovery time.

  Minimally invasive procedures can be used to partially or completely remove body tissues or organs from within the body (eg, nephrectomy, cholecystectomy, and other such procedures) . During such a procedure, the sac, tumor, or other affected tissue or organ must generally be removed through a passage opening in the skin or through a cannula. Various types of entrapment devices have been disclosed to facilitate this procedure.

  For example, U.S. Patent No. 6,057,086 (Clayman et al.) Discloses a surgical tissue bag for percutaneously debulking tissue by shredding. The bag comprises a layer of material that resists penetration, a layer of water resistant material and a drawstring. In the disclosed method of use, the bag is placed in a body cavity, the body tissue or organ is placed in the bag, the opening of the bag is pulled through an incision in the skin, and the body cavity Leaving the distal end of the bag containing the tissue or organ in it, then inserting a morcellator into the bag, then reducing the tissue or organ and aspirating it from the bag To do.

  Patent Document 2 (Wilk et al.) Discloses a planar membrane having a planar membrane with a filament attached to its corner. The membrane is placed in the body cavity and the filament extends outside the body through the trocar cannula. The organ or tissue to be removed is placed on the membrane, the filament is pulled to close the membrane around the organ, and if the organ is sufficiently deformable, it is pulled through the cannula. For example, if the organ is not sufficiently deformable due to the presence of gallstones, forceps or other instruments are used to disrupt the stone or tissue.

Improvements to the prior art capture devices are disclosed in US Pat. These disclosures are hereby incorporated by reference in their entirety.
US Pat. No. 5,037,379 US Pat. No. 5,074,867 US Pat. No. 5,647,372 US Pat. No. 5,465,731

  The problem of the present invention is that it can be used in any procedure (including but not limited to laparoscopic procedures) where the passage into the body is restricted to a relatively small passage area, with or without a cannula. It is to provide a device for removing body tissue from within the body that can be found.

(Summary)
The present disclosure relates to an apparatus for removing body tissue from within a body as part of a minimally invasive surgical procedure. The apparatus includes a pouch assembly and a pouch support. The pouch assembly includes a number of sac, where each sac has a different diameter, thereby forming a sac arrangement that is staggered or stepped in diameter. Each sac has a mouth at one end. One of these sacks (preferably the most distal sac) has a closed end, thereby forming a cavity in the sack, while the other sack There is an orifice on the opposite side of the mouth of the sack. The pouch assembly may have a score line in one of the sacks to facilitate removal of the pouch assembly from its support. The pouch assembly may have a score line extending circumferentially around the pouch assembly between the position of the spring structure and the position of the drawstring thread. The pouch support can be attached to the drive structure. This detachment can be simultaneous with pulling the drawstring thread and closing the pouch assembly accordingly.

  The apparatus further comprises: a drawstring thread that forms a smoothly moving fastener ring that is proximal to the releasable end of the pouch assembly. A drawstring thread disposed circumferentially around the pouch assembly; a first end portion of the drawstring thread slidably attached to a second end portion of the drawstring thread; An attachment structure for forming a smoothly moving loop; a tubular portion of the endoscope having a distal end for insertion into the body; and moving the pouch through the endoscope stem (ie, A fastener structure having a drive structure for pushing or pulling; and an aperture for allowing a single thread to pass through the whole; The second end portion of the thread is extending through the aperture, and the aperture has a surface for holding adjacent to this mounting structure, the fastener structure.

  The sac can be made from a material selected from the group consisting of polyurethane and latex and is preferably transparent. One or more reinforcing regions or bands extend circumferentially around the pouch assembly and partially overlap the joint between a pair of adjacent sac. A smoothly moving knot is a preferred mounting structure.

  A fastener structure is provided near the distal surface of the pusher structure. The pusher structure may be an elongated rod that is slidably disposed within the tubular portion. In the embodiments described below having only one drawstring thread, the aperture of this fastener structure allows only one filament to pass through the fastener structure. It has a diameter that is large enough, but smaller than this mounting structure. The aperture may be oriented parallel to the longitudinal axis of the pusher rod or perpendicular to the longitudinal axis of the pusher rod.

  The apparatus may further comprise a structure (eg, a spring structure) for resiliently opening the openable end of the pouch assembly, the structure being against the openable end of the pouch assembly. Can be moved between an elongated configuration, a narrow closed configuration, and a round open configuration, and the spring structure is resiliently biased against the open configuration Is done. The spring structure (which can support the pouch assembly and open the pouch assembly) is attached to the distal end of the drive structure and slides through the tubular portion when in the closed configuration. It can be moved elastically to its open configuration when possible and when moved outside of this tubular section. The spring structure may comprise two elastic prongs, each elastic prong having a proximal end portion having a side surface, the side surface being a proximal end portion of the other elastic prong. Each of the elastic prongs further has a distal end portion, the distal end portion being attached to both end portions. An attached flexible membrane (eg, shrink wrap tubing) is coupled to the distal end portion of the other prong.

  The apparatus preferably further comprises at least one gas sealing structure (eg, a coating of viscous sealing material applied to the outer surface of the pusher structure and the drawstring thread). A knife or other cutting structure may be provided to cut the drawstring thread.

  A further aspect of the present disclosure is a method for retrieving tissue. This device is inserted through a cannula that has been inserted into the body. The pouch assembly is deployed by advancing the drive structure. This body tissue is cut if necessary and placed in a pouch assembly. The pouch assembly is then closed and removed from the device. The neck of the pouch assembly can then be brought to the distal end of the trocar and the entire assembly is removed. Alternatively, the pouch assembly containing a sample of body tissue can be “waited” by leaving the pouch assembly in the body cavity by a later time during the surgery. During this surgery, the pouch assembly can be removed with the same cannula, with another cannula, or through an opening in the body tissue wall. In order to facilitate removal through the cannula, weight loss of the body tissue specimen is also contemplated, eg, by chopping or cutting.

In addition to the above, the present invention provides the following:
(Item 1)
A surgical device for removing tissue from within a body during a surgical procedure, the device comprising:
A pouch assembly comprising a support and a pouch, the pouch comprising at least a first sac having a first diameter and a second sac having a second diameter, the first sac comprising: An open distal end in fluid communication with the open proximal end of the second sac, the first diameter is greater than the second diameter, and the second sac is closed A pouch assembly having a distal end, the pouch being sized and configured to receive the tissue;
A drawstring operably connected to a proximal region of the first sac; and an elongated tubular member for introducing the pouch, the pouch assembly being attached to the elongated tubular member Tubular members,
A surgical device comprising:
(Item 2)
The surgical apparatus according to claim 1, wherein a proximal end of the first sac has a proximal sleeve for receiving a spring member supported by the elongated tubular member.
(Item 3)
The surgical apparatus of claim 2, wherein the first sac has a distal sleeve disposed distally of the proximal sleeve.
(Item 4)
The surgical apparatus of claim 3, further comprising a drawstring disposed in the distal sleeve.
(Item 5)
The surgical apparatus of claim 4, wherein the first sac defines a weakened portion adjacent to the support.
(Item 6)
The surgical apparatus of claim 1, wherein the pouch is formed from a translucent material.
(Item 7)
The surgical apparatus of claim 1, wherein the first sac has a substantially uniform diameter.
(Item 8)
The surgical apparatus of claim 7, wherein the second sac has a substantially uniform diameter.
(Item 9)
The surgical apparatus of claim 1, wherein the first sac has a tapered configuration.
(Item 10)
The surgical apparatus of claim 9, wherein the second sac has a tapered configuration.
(Item 11)
The surgical apparatus according to item 1, wherein the pouch has a reinforcing band that partially overlaps the first sac and the second sac.
(Item 12)
The surgical apparatus of claim 1, wherein the elongate tubular member has a drive rod disposed within the elongate tubular member, and wherein the pouch assembly is operably attached to the drive rod.
(Item 13)
The tubular member is sized such that the pouch assembly is received within the tubular member and the support is attached to the drive rod so that the drive rod is secured to the pouch assembly. The surgical apparatus of claim 12, wherein the pouch assembly moves from a first position disposed within the tubular member to a second position where the pouch assembly exits the tubular member.
(Item 14)
The surgical apparatus of claim 13, wherein the pull string is received in the tubular member and attached to a handle for pulling the pull string proximally and thereby closing the pouch.
(Item 15)
The surgical rod of claim 14, wherein the drive rod is attached to a handle and is for pulling the handle to move the drive rod from the first position to the second position. apparatus.

Detailed Description of Preferred Embodiments
As used herein with reference to this disclosure, the terms “laparoscope” and “endoscope” are interchangeable and are inserted into a small incision in a cannula or skin An instrument having a relatively narrow operating portion for it, or a surgical procedure in which such an instrument is employed. The use of the term “laparoscope” herein is not to be construed to exclude “endoscope”, but the term “endoscope” is used herein. Use is not to be interpreted as excluding “laparoscope”. In contrast, the present disclosure can be used in any procedure (including but not limited to a laparoscopic procedure) with or without a cannula where the passage into the body is limited to a relatively small passage area. It is believed that applications can also be found.

  An example of a prior art capture device is illustrated in FIG. As shown in FIG. 1, a prior art pouch 10 includes a captured tissue specimen 40 that has been removed from a body cavity 30 through an opening 20 in the direction indicated by the arrow. Depending on the size of the tissue specimen 40 being recovered and the outer shape of the pouch 10, the tissue specimen 40 may be randomly agglomerated or “globulated” inside the pouch 10, thereby opening the aperture. It is conceivable that the collection of the tissue specimen 40 through the unit 20 is inhibited. FIG. 2 illustrates tissue specimen 40 retrieval using a pouch assembly 290 according to one embodiment of the present disclosure. The pouch assembly 290 includes a number of sacks of various diameters that are operably connected to each other. This is discussed in further detail herein below. As shown in FIG. 1, using the same size tissue specimen 40 to retrieve the pouch assembly 290 through the opening 20, the tissue specimen 40 of the tissue specimen 40 is retrieved when the pouch assembly 290 is retrieved from the body cavity 30. Aggregation or clumping is minimized.

  Referring specifically to FIG. 3, the takeout pouch or pouch assembly 290 includes a first sac 260, a second sac 270, and a third sac 280. Each sack is formed from a flexible film or sheet, which is preferably a substantially transparent polymeric material. One preferred material is a polyurethane sheet, although other biocompatible materials (eg, latex) that can form a flexible membrane can be used. The material is preferably selected between about 0.001 and about 0.005 inches thick, although other ranges of thickness can also be used if appropriate. Preferably, this material is transparent so that the contents of the pouch assembly 290 can be seen. In a preferred configuration, each sac is formed from an aromatic polyester type thermoplastic polyurethane, such as Dureflex® (a product of Deerfield Urethane, Inc. (Whattery, Massachusetts)), which sac material is desirably Impervious to liquids and / or gases, and the sac material does not accept cancer cells.

  The pouch assembly 290 can be any size suitable for organ capture or removal purposes. In an embodiment of the present invention, this first sack 260 has a diameter D1, the range being from about 1.5 inches to about 6.0 inches. Overall, the pouch assembly 290 has a depth of about 2 inches to about 10 inches and has a volume capacity of up to about 2.0 liters of water, depending on the dimensions of the pouch assembly 290.

  The first sack 260 includes a mouth 262 and an orifice 264 at opposite ends that define a throat 267 between the ends. Preferably, the diameter of the throat 267 is equal to the diameter D1, which is substantially uniform from the mouth 262 to the orifice 264. Alternatively, the first sac 260 may taper from the mouse 262 to the orifice 264 to form a tip-cut conical shape or a tip-cut inverted cone shape. In addition, other shapes and configurations of this sac are contemplated. The mouse 262 has both an open configuration and a closed configuration, while the orifice 264 only has an open configuration.

  In particular, the first sac 260 has a straight portion weakened by perforation or more preferably by a notch, the straight portion being between a respective proximal sleeve 263 and a distal sleeve 266. Extending circumferentially around the mouth 262 of the first sack 260. The score line 265 can be created by inducing heat to create a straight portion that is thinner than the thickness of the original material to facilitate breakage of the material along the score line 265. Thickness.

  This proximal sleeve 263 is adapted to receive a spring member 230 described below. This distal sleeve 266 is adapted to receive the drawstring 250. When the pull string 250 is pulled with sufficient force to close the mouth 262 of the first sack 260 distal to the score line 265, the score line 265 is adapted to break, thereby At the same time as the mouth 262 is closed, a quick separation of the pouch assembly 290 from the spring member 230 is provided. Obviously, alternative structures can also be utilized to separate the pouch assembly 290 from the spring member 230 (eg, by pulling with a gripper or cutting with scissors).

  Still referring to FIG. 3, the second sac 270 has a mouth 272 and an orifice 274 at opposite ends, the opposite ends defining a throat 277 between the ends. Similar to the first sac 260, the second sac 270 has a diameter D2, which is substantially uniform from the mouth 272 to the orifice 274. The mouth 272 is open and is in communication with the throat 267 of the first sack 260. The diameter D2 or the diameter of the mouth 272 is preferably smaller than the diameter D1 or the diameter of the orifice 264. When configured in this manner, the respective throats 267 and 277 of the first sac 260 and the second sac 270 are in fluid communication with each other, and the diameters of the sac provided in the pouch assembly 290 are slightly different. Alternatively, a stepped arrangement is formed. Alternatively, this second sac 270 can taper from the mouth 272 to the orifice 274 to form a pointed-cut cone shape or a tip-cut inverted cone shape. In addition, other shapes and configurations of the sack are also contemplated.

  The third sack 280 includes a mouth 282 and a base 284 at opposite ends. The mouth 282 is open while the base 284 is closed, defining a cavity 287 therein. This cavity preferably has a uniform diameter D3 throughout. This port 282 is in fluid communication with the throat 277 of the second sac 270. The diameter D3 or the diameter of the mouth 282 is preferably smaller than the diameter D2 or the diameter of the orifice 274. In this configuration, the throats 267, 277, and 287 are in fluid communication with each other, forming an arrangement in which the pouch assembly 290 has a slightly different diameter. Alternatively, the third sac 280 may taper from the mouth 282 to the base 28 to form a tip-cut conical shape or a tip-cut inverted cone shape. In addition, other shapes and configurations of the sac are contemplated.

  Referring now to FIG. 3A, an alternative embodiment of the pouch assembly 290 is disclosed. A pouch assembly 290A according to this embodiment comprises the same or similar components as the embodiment shown in FIG. 3A, and further comprises a reinforcing band or region R. This reinforced region R partially overlaps the junction between a pair of adjacent sac orifices and mouths (eg, orifice 264 of sack 260 and mouth 272 of sac 270). The dimensions (ie, thickness and / or height) of this reinforced region R can include many factors, including but not limited to the dimensions of the pouch assembly 290A, the dimensions of the adjacent sack, and the work being performed. Not). The reinforced region R improves the overall stiffness of the pouch assembly 290A and helps maintain the pouch assembly 290A with a gradually offset or stepped shape. In addition, this reinforced region R improves the strength of the joint between its adjacent sacs, thereby minimizing or collecting the possibility of these sacs becoming separate during a surgical procedure. The size and / or mass of the tissue sample is increased. In preferred embodiments, it is also contemplated that this reinforced region R extends circumferentially around the pouch assembly 290A, but may only extend relative to a portion of the periphery of the pouch assembly 290A.

  Alternatively, as illustrated in FIG. 3B, another embodiment of the pouch assembly 290B includes a reinforced region R having a plurality of reinforced sections R1, spaced circumferentially and forming a gap therebetween. To do. Each reinforced section R1 preferably has substantially the same dimensions (ie, thickness, height and width), but the dimensions of the reinforced section R1 are the same as discussed with respect to the embodiment of FIG. 3A or It is also anticipated that it may fluctuate for similar reasons. As in the previous embodiment, the reinforced region R may extend circumferentially around the pouch assembly 290B or may extend only for a portion around it. In either the embodiment of FIGS. 3A or 3B, this enhancement region R may be included in some or all of this pair of adjacent sac.

  Alternatively, the pouch assembly may only comprise two sac, where the second sac has a closed end opposite its mouth and this end is in the second sac. Define the cavity. In other embodiments of this disclosure, the additional sac may comprise, for example, more than three sac, with the last or most distal sac having a closed end opposite its mouth To define a cavity in the sack. These alternative configurations increase the flexibility and availability of the pouch assembly 290 of the present disclosure. The pouch assembly can be formed from a separate sac, where each adhesive is glued or bonded together using known methods so that the sac is substantially liquid tight. The Alternatively, the pouch assembly can be formed monolithically using known methods to create an arrangement in which the provided sac is gradually offset in diameter. The pouch assemblies of these alternative embodiments may comprise a reinforcement band or region as discussed above.

  Referring now to FIGS. 4, 5, and 6, the laparoscopic removal pouch and applicator assembly includes an elongate tube 180 that is inserted through a trocar cannula for endoscopic or laparoscopic procedures. Is to be dimensioned to be possible.

  Still referring to FIGS. 7A, 7B, 8, 8A, and 9, the drive rod or bar is an elongated, generally cylindrical member that is slidably disposed through the lumen of the tube 180. FIG. The drive rod 190 includes a distal pushing end 191 and is attached to the pouch assembly to remove the pouch from an undeployed position contained within the outer tube 180 (shown in FIG. 5). To a deployed position (shown in FIGS. 4 and 18) that is distal to the outer tube 180. The spring retainer slot 192 extends longitudinally through the drive rod and opens to the distal end 191. The aperture 193 (FIG. 8) extends across the drive rod 190 to the opposite side of the spring retainer slot 192. Pin 200 is placed through aperture 193 (FIG. 6) and through apertures 231b and 232b to secure spring 230 within retainer slot 192 (see FIG. 6).

  The drawstring aperture 194 extends longitudinally through a drive rod that opens distally at the end 192. The drawstring aperture 194 opens proximally into the drawstring slot 195 (see FIG. 7A), which extends longitudinally along the drive rod 190. The drawstring slot 195 terminates in the slot 197 at the proximal end of the drawstring slot. Proximal slot 197 is adapted to receive finger loop 130. The drive rod 190 also includes a peripheral slot 196 for receiving O-rings 210a, 210b, and 210c. This O-ring helps maintain airtightness and / or helps keep the drawstring in place while allowing the drive rod 190 to slide through the tube 180. As shown in FIG. 8A, the O-ring 210a includes an inwardly pointing projection 210d to provide additional liquid and air tightness.

  The drive rod 190 is preferably made from a strong polymer material. A suitable material for making the drive rod 190 is a polycarbonate plastic containing 20% glass fiber filler. If gamma sterilization is desired, this material has the additional advantage of being stable to gamma radiation. Other materials suitable for the purposes discussed herein can also be used, as is known in the art. Close tolerances are observed to maintain hermeticity within the instrument. The outer diameter of the drive rod 190 is slightly smaller than the inner diameter of the tube 180, and the drive rod 190 slides in the longitudinal direction through the tube. In addition, the drive rod 190 is preferably viscous to ensure that no gas enters or exits the body through its seal when gas is blown into the operating site (eg, peritoneum or other body cavity). As a sealing material, it is coated with a biocompatible lubricant. Although any biocompatible lubricant that functions as a viscous seal material can be used, if gamma sterilization is desired, the selected biocompatible lubricant should be gamma-stable. A locking tab 105 (FIG. 5) is provided to prevent premature activation of the instrument during transport. The locking tab includes a snap-fit engagement structure for engaging the drive rod slot 198 (FIG. 7B). When so engaged, the drive rod cannot be pushed distal to the tip. Here, the locking tab 105 engages the proximal ends of the handle portions 110, 120. In order to operate this instrument, the surgeon must first release the locking tab by pulling the locking tab out of the instrument.

  The spring 230 is preferably formed from two flexible and elastic strips 231 and 232 (FIG. 6). The strips together form a generally circular ring to support the periphery of the mouth 264 of the pouch assembly 290 when unstressed or freely expanded. Each strip 231 and 232 has proximal end portions 231a and 232a, respectively, and apertures 231b and 232b extend through the sides of these proximal end portions. The proximal end portions 231a and 232a are adapted to be received in the slot 192 of the drive rod 190 so that the longitudinal movement of the drive rod 190 in the manner described below can be 230 and attached pouch assembly 290 are moved. Apertures 231b and 232b are configured to line up with the aperture 193 of the drive rod, thereby allowing the pin 200 to be placed therethrough. The distal ends 231c and 232c are each in an opposing relationship, and these distal ends are joined by tubing 240 made from a polymeric material (preferably a shrink wrap material). In addition, a plurality of arrows or other indicators are placed around the tubing 240 to aid in the manufacturing assembly of the instrument and the surgeon properly orients the pouch assembly 290 prior to organ capture and removal. Can also be an aid. The spring 230 is preferably manufactured from an elastic metal (eg, stainless steel). Other elastic materials are also envisaged and include TINEL brand superelastic metals and plastics commercially available from Raychem Corporation (Menlo Park, California). In other embodiments, the spring 230 may be formed from an integral elastic strip or piece of material.

  Referring now to FIGS. 6, 10 and 11, the finger loop 130 includes a ring portion 134 for engaging the user's fingers. The distal portion of the finger loop includes a protrusion 131 for engaging a slot 197 in the drive rod 190. In this slot, the protrusion 132 is fixedly attached. The protrusion 131 includes a key portion 131a that engages with a corresponding notch in the handle portion 120 when the pouch is fully deployed, and relative to the drive rod within the device. Prevent excessive rotation. The aperture 132 extends longitudinally from the distal opening 132a to the proximal opening 132b and receives the thread 250 in the aperture. At its proximal end, the finger loop 130 may have a fitting 135 to releasably hold the pull ring 160. The fixture 135 includes spaced apart, generally proximally pointed prongs 135a and 135b that are proximal to receive snap fits on the struts 170 of the pull ring 160. A mouth 135c that is open in the direction is defined. In the alternative embodiment shown in FIG. 10A, the ring portion 134 of the finger loop 130 has an internal recess 171 dimensioned to releasably hold the pull ring 160 (FIG. 10C). The internal recess 171 is defined by the inner wall 173 and the shoulder 175 of the ring portion 134. The inner wall 173 includes at least one indentation 177 to receive a snap fit of the corresponding protrusion 179 of the pull ring 160. In a preferred embodiment, three peripheral indentations 177 are disposed along the inner wall 173, one on its distal side and two opposite each other on its proximal side. As shown in FIG. 10B, the ring portion 134 may also include a protrusion 183 so that the instrument can be grasped with more than one finger, if desired. In a preferred embodiment, the protrusion 183 includes a tapered end 185 that extends outwardly from the ring portion 160 in a cross direction. The tapered end 185 may be rounded and may be provided with a slight bend to facilitate gripping with more than one finger, if desired. The knife 140 is mounted laterally across the mouth at its distal end, with the sharp knife edge 140a pointing proximally. Knife 140 is secured in fixture 135 by a pin 150 disposed through aperture 137 in finger loop 130. The knife edge 140a functions to cut the drawstring 250 as described below. Alternatively, knife 140 can be an insert that is molded or attached onto finger loop 130.

  Referring to FIG. 6, handle portions 110 and 120 are fixedly coupled together to form an integral ring handle. The ring handle is fixedly attached proximally to the proximal end of the tube 180 to receive the user's fingers and facilitate instrument operation.

  The pull ring 160 is a finger ring for easily pulling the pull string 250. A finger ring is attached to the drawstring, preferably using an adhesive. In one embodiment, the strut 170 (which can be an integral part of the pull ring 160) is pivotally attached in a snap-fit engagement to the mouth 135c of the fitting 135 (FIG. 10), and is described below. For the reasons discussed, it can be removed by separating the ring 160 from the ring portion 134 by applying a pulling force to the struts. When utilizing the strut 170, the pull ring 160 preferably includes a protrusion 161 that engages a corresponding indentation in the finger loop 130 to cause inadvertent or unintentional rotation of the pull ring 160. It is possible to prevent. In an alternative embodiment, FIG. 10B, the pull ring 160 includes at least one protrusion 179 for snap-fit engagement with the corresponding recess 177 of the ring portion 134, and the pull ring is discussed below. For this reason, it can be removed by applying a pulling force or pushing force sufficient to separate the pull ring 160 from the ring portion 134. In a preferred embodiment, the pull ring is prominently colored to alert the user regarding the orientation of the pouch assembly 290.

  The drawstring 250 is tied to one end relative to the pull ring 160 and passes through the aperture 132 in the finger loop, through the drawstring slot 195 in the drive rod 190, through the drawstring aperture 194, and down. By passing through the side tubular space 266 (see FIG. 6), it extends around the mouth 264 of the first sack 260. This drawstring 250 is preferably coated with a biocompatible lubricant as a viscous sealing material to ensure that no gas enters or exits the peritoneum through the aperture 194. Any biocompatible lubricant that functions as a viscous sealing material can be used, but if gamma sterilization is desired, the biocompatible lubricant selected should be gamma-stable. The ends of the drawstring 250 are brought around, and the drawstring 250 is tied by a knot 251 to form a loop 252. The knot 251 is a “smoothly moving knot” (ie, a knot that slides along a rope or line and is tied in a loop). Thus, the loop 252 tightens when the line's standing element is pulled. For proper operation, the knot 251 should have a size that is larger than the diameter of the aperture 194 (FIGS. 6Aa and 6B). When the pull string 250 is pulled in the proximal direction, the knot 251 is pulled to the distal opening of the aperture 194. In this case, the knot 251 is adjacent to the distal surface 191 of the drive rod 190. Aperture 194 is large enough to accommodate a single strand or filament of drawstring 250, but with minimal clearance to help keep hermetic with the additional sealing provided by the biocompatible lubricant. Have However, the aperture 194 is not large enough to allow the knot 251 to pass through the aperture. Thus, the knot 251 is held in place at the same time as the drawstring 250 is pulled proximally, thereby closing the loop 252. This in turn closes the mouth 262 of the first sack 260 and disengages the pouch assembly 290 along the score line 265. Using a smoothly moving knot allows the closure and opening of the pouch to be achieved by a single actuating filament of the drawstring 250 moving through the device. The aperture or thread path in a laparoscopic instrument for accommodating a single filament of a thread need not have a diameter large enough to accommodate two or more filaments of a drawstring thread.

  A further advantage is that it maintains a proper hermeticity in the aperture 194 when a single filament is moved therethrough, rather than when two or more filaments of a thread are placed therethrough. It is easy. Device configurations with only one actuating filament are preferred, but devices that employ multiple actuating filaments from, for example, two or more filaments or a single filament taken are within the scope of this disclosure. It is predicted that

  Any type of smoothly moving knot having an appropriate diameter (e.g., a pull or a knot that moves smoothly, and variations thereof) may be used. This knot should preferably maintain sufficient friction against the drawstring so that when the drawstring is pulled with sufficient tension, the knot slides along the drawstring. This knot should also preferably slide in both the distal and proximal directions to close, if necessary, so that the pouch can be opened after removal to facilitate removal of tissue.

  The present disclosure contemplates structures and / or devices other than knots to have the same functionality as described above. For example, rings, eyelets, etc. can be used. As shown in FIG. 6B, one end of the drawstring filament is attached to a ring member 220, which has an aperture 221 for receiving the drawstring 250. When the drawstring 250 is pulled proximally, the ring member 220 is adjacent the proximal surface 181 at the aperture 194 and the drawstring 250 can be pulled through the aperture, thereby closing the loop 252. become.

  Thus, any structure or device for slidably attaching one end of a drawstring to a drawstring thread to form a retractable loop (ie, a smoothly moving loop) is within the scope of this disclosure. Expected to enter.

  Tube 180 is of a diameter that allows it to be slidably placed through a trocar cannula for use in endoscopic or laparoscopic surgery, and generally has a diameter of about 0.25 inches to about 0. .50 inches and between about 10 inches and about 15 inches in length, but other dimensions may also be used if appropriate for the surgery being performed. Tube 180 slidably receives drive rod 190 and, if not deployed, spring 230 and pouch assembly 290. In the initial unused state, the pouch assembly 290 is rolled and the spring portions 231 and 232 are relatively straight and are disposed within the tube 180. As the drive rod 190 is advanced, the spring 230 connected to the drive rod exits the distal end of the tube 180 and snaps open elastically, thereby deploying and opening the pouch assembly 290. Tube 180 is preferably formed from a metal (eg, stainless steel) and preferably coated with shrink wrap plastic (eg, shrinkable polyethylene fiber glass, or polyvinyl chloride of a grade suitable for use in surgical procedures). Is done.

  Minimally invasive surgery in the abdomen usually requires placing one or more trocar assemblies in the abdominal wall to provide a passage to the peritoneum for surgical instruments. The trocar assembly may comprise an obturator having a sharp, penetrating tip, a cannula having a proximal section that typically includes a tube and a valve and a sealing structure. The surgeon inserts the trocar assembly into the abdominal wall and then removes the obturator so that the cannula is inserted into the body cavity and the proximal section remains outside the body. Gas is then blown into the body cavity. Additional cannulas can be inserted, and various surgical and optical viewing instruments can be inserted through several cannulas. The cannula sealing structure helps to prevent gas in and out between the inside of the cannula and the outside of the instrument. As described above, the instrument generally has an internal sealing structure to prevent gas from entering or exiting the interior of the instrument. The placement of the trocar cannula and the insertion of instruments therethrough is performed according to methods and devices known and commonly available to those skilled in the art.

  With reference now to FIGS. 12-22, a method of using the apparatus of the present disclosure in minimally invasive surgery will now be described. By way of illustration, surgical procedures in which the methods of the present disclosure can be used include, but are not limited to, nephrectomy, cholecystectomy, appendectomy and the like.

  FIG. 12 shows a schematic diagram of a first trocar cannula 300 inserted through the wall of body tissue 400 to obtain a passage to a body cavity (eg, the peritoneum). The applicator assembly 100, in a position where the specimen collection pouch assembly 290 is not deployed, is inserted through the cannula 300 in the direction of arrow A. As a result, the distal end of applicator assembly 100 is positioned within the body cavity. As shown in FIG. 12, the applicator assembly is in an initial state and the specimen collection pouch assembly 290 is retained in the tube 180. The pull ring 160 is disposed on the top of the column 170. This locking tab 105 is then removed allowing the instrument to operate.

  Referring now to FIG. 13, the drive rod 190 is advanced distally in the longitudinal direction by the surgeon pushing the finger loop 130 as indicated by arrow B. The finger loop of this ring portion 110 (and 120) can be gripped by the user while moving the finger loop 130. This movement of the drive rod 190 advances the pouch assembly 290 beyond the distal end of the tube 180, where the spring 230 is no longer held by the tube 180 and is therefore elastically moved into its substantially round configuration. Quickly open, thereby moving the mouth 262 of the first sack 260 from its closed configuration to its open configuration.

  Referring now to FIG. 14, an atraumatic forceps or gripper 500 can be introduced through the second trocar cannula 310 and manipulated to gently unwind the pouch assembly 290 if necessary.

  Referring to FIG. 15, a sample of body tissue 410 is cut and placed in pouch assembly 290. Specimen 410 can be processed as needed, i.e., minced or otherwise divided prior to removal from the body cavity.

  Referring to FIG. 16, the pull ring 160 pivots on the post 170 in the direction indicated by arrow C to the position illustrated in FIG.

  Referring to FIG. 17, the pull ring 160 is grasped and pulled, thereby allowing the strut 170 to be removed from the fitting 135 and the pull ring 160 to be removed from the finger loop 130.

  When the pull ring 160 is pulled (FIG. 18), the pull string 250 is moved in the proximal direction, thereby disengaging the pouch assembly 290 from the spring support 230 along the score line 265. Continuously pulling the drawstring 250 causes the smoothly moving knot 251 to be adjacent the pusher distal end 191, thus reducing the loop or loop 252 and closing the mouth 262 of the pouch assembly 290.

  Referring to FIG. 19, the drawstring 250 is inserted into the mouth 135c of the fixture 135 and cut by the knife 140 to allow subsequent removal of the device with the closed pouch remaining inside the body cavity. .

  Referring to FIG. 20, the finger loop 130 is pulled to pull the spring 230 back into the tube 180, where the spring 230 collapses into a relatively straight configuration prior to its deployment. Returned to allow removal of device 100 from cannula 300. The drive rod 190 is not fully retracted from the proximal end of the tube 180. This is because the complete withdrawal of the drive rod allows the spring 230 to exit and later open outside the proximal end of the device.

  At this point, the drawstring 250 is located in the cannula and, as shown in FIG. 22, the pouch assembly 290 containing the tissue specimen 410 is passed through the cannula until the end of the pouch assembly 290 reaches the neck of the trocar. By pulling on the drawstring 250, it can be quickly removed through the trocar site, and both this end and the trocar can be removed together, or the trocar can be removed first and then removed through the same incision. Can be. Conveniently using many different sized sacks to form the pouch assembly 290 minimizes agglomeration of the tissue sample 410, thereby facilitating retrieval of the pouch assembly 290 containing the tissue specimen 410. . Still further, the tissue specimen 410 tends to be similar to the sausage shape of the sac, which is gradually offset in diameter in the pouch assembly 290, thereby making it easier to retrieve the pouch assembly 290 containing the contents. become.

  Alternatively, when the mouth 262 of the pouch assembly 290 is held tightly closed with a pull string, the pull string 250 may be attached to a suitable endoscopic instrument (e.g., a body cavity) as shown in FIG. Can be grasped by a grasping tool) and later removed during surgery. If necessary, the incision may be enlarged to allow passage of the pouch assembly 290 and specimen 410 through the incision. However, it is instead anticipated that the specimen 410 contained in the pouch assembly 290 can be removed through the cannula if it is sufficiently small or divided as discussed above.

(Summary)
Specimen extraction device includes a pouch assembly made from a flexible membrane, a pouch support, a pull string thread that forms a smoothly moving cuff disposed around the end of the pouch and arranged circumferentially, an endoscope A pusher rod having a tubular portion and an aperture to allow passage of a single thread is provided. When the drawstring thread is pulled, the knot stops at the aperture and the loop is closed, thereby closing the mouth of the pouch. The pouch assembly is removable from the device.

  Although the above description includes many specific examples, these specific examples should not be construed as limitations on the scope of the present disclosure, but merely as exemplifications of preferred embodiments of the present invention. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the present disclosure.

Preferred embodiments of the present disclosure are described hereinbelow with reference to the drawings.
FIG. 1 is a side cross-sectional view of a prior art specimen bag containing a specimen partially removed from a body cavity. FIG. 2 is a side cross-sectional view of a specimen bag according to the present disclosure that includes a specimen partially removed from a body cavity. FIG. 3 is a partial cutaway view of the front of a specimen removal pouch assembly according to an embodiment of the present disclosure. FIG. 3A is another embodiment of the specimen removal pouch assembly of FIG. 3 having a reinforced region. FIG. 3B is an alternative embodiment of the specimen removal pouch of FIG. 3A. FIG. 4 is a perspective view of the deployed configuration of the apparatus of the present disclosure. FIG. 5 is a perspective view of the device in the initial undeployed configuration. FIG. 6 is an exploded perspective view of this apparatus. FIG. 6A shows a knot that moves smoothly in a perspective view. FIG. 6B alternatively shows an eyelet structure for slidably attaching a first end portion of a drawstring thread to a second end portion to form a smoothly moving loop. FIG. 7A is a plan view of the drive rod. FIG. 7B is a front view of the drive rod. FIG. 8 is a perspective view of the drive rod. FIG. 8A shows a side view of the O-ring 210a. FIG. 9 is an end view of the drive rod. FIG. 10 is a bottom view of the finger loop. FIG. 10A is a perspective view of an alternative finger loop. FIG. 10B is a perspective view of an alternative finger loop. FIG. 10C is a perspective view of a pull ring for engagement with an alternative finger loop. FIG. 11 is a view of the attachment at the proximal end of the finger loop in a separated state. FIG. 12 illustrates insertion of the device of the present disclosure into a body cavity through a trocar cannula. FIG. 13 shows the development of the specimen extraction pouch. FIG. 14 shows the development of the specimen extraction pouch. FIG. 15 shows the capture of the tissue specimen. FIG. 16 illustrates the closure of the pouch. FIG. 17 illustrates the closure of the pouch. FIG. 18 illustrates the closure of the pouch. FIG. 19 illustrates the cutting of the drawstring. FIG. 20 illustrates removal of the device from the cannula. FIG. 21 illustrates a subsequent procedure for pouch removal. FIG. 22 illustrates a subsequent procedure for pouch removal.

Claims (20)

A surgical device for removing tissue from within a body during a surgical procedure,
The device is
A pouch assembly including a support and a pouch, wherein the pouch is sized and arranged to receive the tissue;
An elongate tubular member for introducing the pouch, wherein the pouch assembly is attached to the elongate tubular member;
A drawstring operably associated with the elongate tubular member and coupled to the pouch assembly;
With
The pouch includes at least a first sac having a first diameter and a second sac having a second diameter, the first sac having an open proximal end and an open distal end. And the open distal end of the first sac is in fluid communication with the open proximal end of the second sac, whereby the open distal end of the first sack and the second sac A joint between the open proximal end of the second sac and the second sac has a closed distal end;
A reinforcement band is operably disposed at the joint formed between the open distal end of the first sac and the open proximal end of the second sac, and the reinforcement A portion of the band extends partially into the second sac, so that a strengthened stepped region is formed between the first and second sac, the flexibility of the pouch A single substantially substantially circumferentially unreinforced region without the reinforcing band extends between the portion of the reinforcing band extending to the second sack and the second sack. A surgical device, wherein the single substantially circumferentially uniform unstrengthened region includes a diameter equal to that of the second sac. The surgical apparatus according to claim 1, wherein the diameter of the first sac is greater than the diameter of the second sac. The open distal end of the first sac and the open proximal end of the second sack are supported by the reinforcing band, the reinforcing band being the open distal of the first sack. And a stepped region having a first diameter for supporting the distal end and a second diameter for supporting the open proximal end of the second sac. The surgical apparatus according to claim 1, wherein the surgical apparatus is formed between the open distal end of the second sac and the open proximal end of the second sac. The surgical apparatus according to claim 3, wherein the first diameter of the reinforcement band is different from the second diameter of the reinforcement band. The reinforced band includes a plurality of reinforced sections alternating with a plurality of non-reinforced sections, each of the plurality of reinforced sections and the plurality of non-reinforced sections being circumferential along the stepped region The surgical apparatus according to claim 4, wherein the surgical apparatus is spaced in a direction. The surgical apparatus according to claim 1, wherein a proximal end of the first sac has a proximal sleeve for receiving a spring member supported by the elongate tubular member. The surgical apparatus according to claim 6, wherein the first sac has a distal sleeve disposed distally of the proximal sleeve. The surgical apparatus according to claim 7, further comprising a drawstring disposed in the distal sleeve. The surgical apparatus according to claim 8, wherein the first sac defines a weakened portion adjacent to the support. The surgical apparatus according to claim 1, wherein the pouch is formed from a translucent material. The surgical apparatus according to claim 1, wherein the first sac has a substantially uniform diameter. The surgical apparatus according to claim 1, wherein the second sac has a substantially uniform diameter. The surgical apparatus according to claim 1, wherein the first sac has a tapered configuration. The surgical apparatus according to claim 1, wherein the second sac has a tapered configuration. The surgical apparatus according to claim 1, wherein the reinforcement band overlaps the first sac and the second sac. The surgical apparatus according to claim 1, wherein the elongate tubular member has a drive rod disposed within the elongate tubular member, and the pouch assembly is operably attached to the drive rod. The tubular member is sized such that the pouch assembly is received within the tubular member, and the support is from a first position where the pouch assembly is disposed within the tubular member. The surgical apparatus according to claim 16, wherein the surgical rod is attached to the drive rod such that movement of the drive rod is made to a second position where the pouch assembly exits the tubular member. 18. The pull string is received in the tubular member and attached to a handle, the handle being for closing the pouch by pulling the pull string in a proximal direction. The surgical device as described. 19. The drive rod is attached to a handle, the handle pulls the handle to move the drive rod from the first position to the second position. Surgical equipment. The open distal end of the first sac and the open proximal end of the second sac define a passage configured to minimize aggregation of the tissue specimen during removal of the tissue specimen. The surgical apparatus according to claim 1.

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